Bipolar DisorderPhase 3NCT00257972
Study of Aripiprazole in Patients With Bipolar I Disorder
A Phase 3 study testing aripiprazole in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 90 sites in 17 countries.
Trial summary
The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- aripiprazole
- How many people
- 400 participants
- Where
- 90 sitesin 17 countries
- Study dates
- Oct 2004to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of bipolar I disorder, manic or mixed episode
Who cannot join
- First manic or mixed episode
- Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
- Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole
Trial locations and contacts
90 sites in 17 countries.
90 sites in 17 countries
United States20 sites
Local Institution
Austin, Texas
Local Institution
Bellevue, Washington
Local Institution
Columbia, South Carolina
Local Institution
Dayton, Ohio
Local Institution
Deerfield Beach, Florida
Local Institution
Hoffman Estates, Illinois
Local Institution
Jacksonville, Florida
Local Institution
Little Rock, Arkansas
Local Institution
Maitland, Florida
Local Institution
Media, Pennsylvania
Local Institution
Memphis, Tennessee
Local Institution
New York, New York
Local Institution
Newton, Kansas
Local Institution
Newton, Massachusetts
Local Institution
Norristown, Pennsylvania
Local Institution
Oak Brook, Illinois
Local Institution
Philadelphia, Pennsylvania
Local Institution
Raleigh, North Carolina
Local Institution
Riverside, California
Local Institution
Staten Island, New York
France10 sites
Local Institution
Bordeaux
Local Institution
Dole
Local Institution
Grenoble
Local Institution
Jonzac
Local Institution
La Rochelle
Local Institution
Limoges
Local Institution
Marseille
Local Institution
Nîmes
Local Institution
Pessac
Local Institution
Rennes
Italy8 sites
Local Institution
Bassano del Grappa
Local Institution
Cagliari
Local Institution
Florence
Local Institution
Pisa
Local Institution
Roma
Local Institution
Sassari
Local Institution
Trieste
Local Institution
Voghera -Pavia
South Africa7 sites
Local Institution
Durban, KwaZulu-Natal
Local Institution
Observatory, Western Cape
Local Institution
Port Elizabeth, Eastern Cape
Local Institution
Pretoria, Gauteng
Local Institution
Vereeniging, Gauteng
Local Institution
Welkom, Gauteng
Local Institution
Westdene, Free State
Poland6 sites
Local Institution
Choroszcz
Local Institution
Kościan
Local Institution
Krakow
Local Institution
Poznan
Local Institution
Torun
Local Institution
Tuszyn
Estonia5 sites
Local Institution
Pärnu
Local Institution
Tallinn
Local Institution
Tartu
Local Institution
Viljandi Maakond
Local Institution
Voru Maakond
Germany5 sites
Local Institution
Berlin
Local Institution
Jena
Local Institution
Magdeburg
Local Institution
Meunchen
Local Institution
Westersted
United Kingdom5 sites
Local Institution
Burnley, Lancashire
Local Institution
Glasgow, Dumbartonshire
Local Institution
London, Greater London
Local Institution
South Wales, Mid Glamorgan
Local Institution
Surbiton, Middlesex
Czechia4 sites
Local Institution
Brno-Bohunice
Local Institution
Hradec Králové
Local Institution
Opava
Local Institution
Prague
Hungary4 sites
Local Institution
Budapest
Local Institution
Gyula
Local Institution
Kecskemét
Local Institution
Nagykálló
Russia4 sites
Local Institution
Leningrad Region
Local Institution
Moscow
Local Institution
Saint Petersburg
Local Institution
Smolensk
Spain4 sites
Local Institution
Barcelona
Local Institution
Madrid
Local Institution
Valencia
Local Institution
Vitoria-Gasteiz
Bulgaria3 sites
Local Institution
Rousse
Local Institution
Sofia
Local Institution
Varna
Netherlands2 sites
Local Institution
Retranchement
Local Institution
Zaandam
About this study
Official title: Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy
The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.
- Conditions
- Bipolar Disorder
- Being tested
- aripiprazole
- Keywords
- Bipolar Mania
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint in a mania rating scale
Secondary outcomes (1)
Response rate and Clinical Global Impression Scale at endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257972
- Sponsor's protocol ID
- CN138-134
- Status last verified
- May 2008
- First submitted
- 23 Nov 2005
- Last updated
- 8 Nov 2013
- Results posted
- No
Publications
Vieta E, T'joen C, McQuade RD, Carson WH Jr, Marcus RN, Sanchez R, Owen R, Nameche L. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry. 2008 Oct;165(10):1316-25. doi: 10.1176/appi.ajp.2008.07101560. Epub 2008 Apr 1.
PubMed 18381903Vieta E, Owen R, Baudelet C, McQuade RD, Sanchez R, Marcus RN. Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study. Curr Med Res Opin. 2010 Jun;26(6):1485-96. doi: 10.1185/03007991003779380.
PubMed 20429835
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy
- ClinicalTrials.gov ID
- NCT00257972
- Acronym / sponsor ID
- CN138-134
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Mania
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Oct 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 24 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of bipolar I disorder, manic or mixed episode
Key exclusion criteria (3 listed)
- First manic or mixed episode
- Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
- Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aripiprazole | Drug | – |
Primary outcome
Change from baseline to endpoint in a mania rating scale
1 secondary outcome
Response rate and Clinical Global Impression Scale at endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Background: PubMed 18381903Vieta E, T'joen C, McQuade RD, Carson WH Jr, Marcus RN, Sanchez R, Owen R, Nameche L. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry. 2008 Oct;165(10):1316-25. doi: 10.1176/appi.ajp.2008.07101560. Epub 2008 Apr 1.
- Derived from this study: PubMed 20429835Vieta E, Owen R, Baudelet C, McQuade RD, Sanchez R, Marcus RN. Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study. Curr Med Res Opin. 2010 Jun;26(6):1485-96. doi: 10.1185/03007991003779380.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
90 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aripiprazole in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 90 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in United States, France, Italy, South Africa, Poland and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to endpoint in a mania rating scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00257972, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.